25%! This is the percentage of global disease burden caused by neurological conditions. These conditions are the leading cause of disability and the second leading cause of death worldwide.
As our Global Program Safety Lead within Neuroscience, you will provide scientific and strategic leadership to optimize benefit-risk for assigned compounds. You will ensure optimal patient safety and will be responsible for the integration, analysis, and interpretation of internal and external safety information from all sources through lifecycle management.
Your responsibilities will include, but are not limited to:
• Design and develop safety surveillance strategy for products in the development and / or post-approval.
• Responsible for the company’s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.
• Safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
• Support and guide compliance with governmental regulations on Good Pharmacovigilance Practice.
• Provide and contribute trending and safety signal detection and risk management assessment throughout the products’ life cycle.
• Lead the preparation of the safety strategy for health authority responses, in collaboration with other project team members
• Provides expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)
*Some restrictions to flexible working models may apply and will be discussed at interview if relevant
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
• MD preferred (PhD, PharmD also considered)
• Proficiency in English (oral and written)
• 5+ years proven experience within a Global Pharmaceutical Company
• 3+ years in Medical Safety, Benefit/Risk Evaluation
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!